Successful Enrollment of First Five Patients in a New Study
Combining Existing Therapeutic Techniques

Dr. Christopher Owens, a vascular surgeon at the University of
California, San Francisco (UCSF) and the San Francisco Veterans
Affairs Medical Center (SFVAMC), has reached an important milestone
by enrolling five patients in a breakthrough study aimed at
reducing re-narrowing following treatment of blockages of the leg
arteries.

Peripheral artery disease (PAD) affects 10-12 million Americans
and is a significant source of pain and disability. PAD is caused
by a chronic buildup of fatty plaque within the arterial wall and
restricts blood flow to the legs and feet. This can result in pain
in the legs, non-healing ulcers in the feet and amputations in the
worst cases. Many of these patients can be treated by minimally
invasive surgery to open arteries with restricted blood flow or
blockage. Although the minimally invasive techniques such as
balloon angioplasty or stenting of the artery allow a patient to
avoid surgery, they often lead to the buildup of thick scar tissue
that can re-narrow the artery in as many as 50-70% of treated
patients in only one year. In his innovative study, Dr. Owens has
adopted a new minimally invasive technique to deliver an
anti-inflammatory drug to prevent scar tissue buildup after
restoring blood flow.

This study at UCSF and SFVAMC integrates a medical device and
drug that have each been FDA approved. The device - the
Bullfrog® Micro-Infusion Catheter from Mercator MedSystems in
San Leandro, Calif. - can precisely deliver drugs into the inflamed
tissues (the adventitia and perivascular tissues) that surround
diseased and damaged arteries. The catheter is threaded into the
artery and navigated to the treatment site, where a tiny
microneedle is deployed. The drug is injected into the tissues
surrounding the artery and bathes the artery with the drug. Dr
Owens reports that, "this is a very efficient way to deliver the
drug right where it is needed to treat the artery and avoid any
toxic side effects." This device has been used in other clinical
applications in the United States, but this is the first time that
it has been used in diseased peripheral arteries.

In this study, Dr. Owens is using the device to inject the
anti-inflammatory steroid dexamethasone. Dexamethasone is typically
used to treat allergic disorders, skin conditions, ulcerative
colitis, arthritis, lupus, psoriasis, breathing disorders, asthma,
allergies, and arthritis. Dr. Owens continues, "This technique of
diffusing dexamethasone around arteries should reduce procedural
inflammation and lead to more sustained blood flow in the leg so
that the patient does not have to return as soon for another
procedure to re-open the arteries. We're excited to continue with
the study and follow the patients to see if this procedure has a
lasting effect in the treatment of PAD."